Exercise for Brain Health in the Fight Against Alzheimer's Disease

NCT03727360 | Completed Results DMC

• 2 other identifiers: 11159461R01AG057552
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.

Conditions

Healthy Cognition

Keywords

Walking Exercise; Flexibility Exercise; Cognition; Memory; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Rey Auditory Verbal Learning Test Sum of Trials 1-5

  Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.

  Baseline and 6 months

• Famous Name Discrimination fMRI Activation

  Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.

  Baseline and 6 months

Secondary Outcomes (2)

• Peak Rate of Oxygen Consumption (VO2peak)

  Baseline and 6 months

• 6 Minute Walk Test

  Baseline and 6 months

Study Arms (2)

Exercise Training

EXPERIMENTAL

Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.

Other: Exercise Training

Flexibility Control

ACTIVE COMPARATOR

Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.

Other: Flexibility Control

Interventions

Exercise Training OTHER

Supervised exercise conducted four days per week for six months.

Exercise Training

Flexibility Control OTHER

Supervised exercise conducted four days per week for six months.

Flexibility Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old
• Fluent in English
• Willingness to make the time commitment to participate in the project, including randomization to treatments
• Physically inactive (physical activity not more than 2 days per week for the past 6 months)
• Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
• Determined to be safe for MRI

You may not qualify if:

• Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
• Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
• Untreated severe major depression
• Substance abuse or dependence
• Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
• Use of acetylcholinesterase inhibitors (e.g., Aricept)
• Unstable or severe cardiovascular disease or asthmatic condition
• History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
• Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment

Sponsors & Collaborators

• Marquette University: collaborator
• University of Maryland, Baltimore: collaborator
• University of Maryland, College Park: lead
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

University of Maryland, Department of Kinesiology

College Park, Maryland, 20742, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: J. Carson Smith, PhD
• Organization: University of Maryland at College Park

carson@umd.edu

+1 (301) 405-0344

Study Officials

• J. Carson Smith, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 1, 2018
• Study Start: October 8, 2018
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Locations

US (1)